Infant Bacterial Therapeutics (IBT) Q3 2025 earnings summary

Executive summary

• IBP-9414 achieved a 27% reduction in all-cause mortality in preterm infants in a Phase 3 study, supporting its potential to save thousands of lives annually.

• The company is preparing for regulatory submissions in the US (BLA in H1 2026) and Europe (central marketing approval in 2026).

• Focus remains on finalizing manufacturing validation and preparing for product launch, especially in the US.

Financial highlights

• Net sales were SEK 0 for both Q3 and the nine-month period, unchanged from the prior year.

• Operating loss for Q3 was SEK -10.8 million, a significant improvement from SEK -33.8 million in Q3 2024; nine-month operating loss was SEK -48.5 million, improved from SEK -107.9 million year-over-year.

• Result after tax for Q3 was SEK -9.7 million (Q3 2024: SEK -32.7 million); for the nine months, SEK -46.0 million (2024: SEK -103.1 million).

• Cash flow for the nine months was SEK -52.3 million, improved from SEK -102.8 million in the prior year.

• Cash balance at September 30, 2025, was SEK 165.3 million, down from SEK 223.4 million at year-end 2024.

Outlook and guidance

• Capital is considered sufficient to fund operations through the application for marketing authorization.

• Plans to submit a BLA to the FDA in H1 2026 and seek central marketing approval in Europe in 2026.